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Plaque Registration and Event Detection In Computed Tomography (PREDICT)

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ClinicalTrials.gov Identifier: NCT00991835
Recruitment Status : Unknown
Verified March 2013 by Yasuki Kihara, Hiroshima University.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2009
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):
Yasuki Kihara, Hiroshima University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.

Condition or disease
Atherosclerosis Cardiovascular Diseases Coronary Artery Disease

Study Design
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Study Type : Observational
Actual Enrollment : 3015 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography
Study Start Date : October 2009
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Major cardiac events (Cardiac death and acute coronary syndrome) [ Time Frame: 2 years after the CT-scan ]
  2. All-cause death [ Time Frame: 2 years after the CT-scan ]

Secondary Outcome Measures :
  1. All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations) [ Time Frame: 2 years after CT-scan ]
  2. All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure) [ Time Frame: 2 years after the CT-scan ]

Other Outcome Measures:
  1. Coronary plaque progression and managements for serum cholesterol, blood glucose, renal function and blood pressure: Especially impacts of statin on the changes in coronary plaque characteristics [ Time Frame: 2 years after CT ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients reffered to cardiovascular hospital
Criteria

Inclusion Criteria:

  • patients with known or suspected coronary artery disease.

Exclusion Criteria:

  • irregular heart beat,
  • known allergy towards the contrast agent,
  • renal dysfunction,
  • uncontrolled heart failure,
  • previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
  • impossible breath-hold, OR
  • end-stage cancer.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991835


Locations
Japan
Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Investigators
Study Chair: Yasuki Kihara, MD,PhD Hiroshima University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yasuki Kihara, Department of Cardiovascular Medicine, Graduate School of Biomedical Sciences, Hiroshima University
ClinicalTrials.gov Identifier: NCT00991835     History of Changes
Other Study ID Numbers: PREDICT2009
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
 Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases